Salt Lake City, Utah, August 6, 2026
BlueWind Medical, Ltd. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Revi® Extend, its next-generation Implantable Tibial Neuromodulation (ITNM) device designed for the treatment of urgency urinary incontinence (UUI). The new implant extends expected device durability from 10 years to 15 years, strengthening the Revi platform as a long-term, minimally invasive neuromodulation option for patients living with the chronic condition. BlueWind Medical plans to begin a limited U.S. commercial launch in the fourth quarter of 2026, marking an important regulatory and commercialization milestone for the company. Revi Extend builds on BlueWind’s established Revi System and is designed to provide targeted stimulation of the posterior tibial nerve through a small implant positioned near the ankle and activated using an external wearable device.
Revi Extend Increases Implant Durability to 15 Years
The key advancement of Revi Extend is its 15-year durability, which BlueWind Medical says is intended to reduce the long-term treatment burden associated with UUI. The implant is placed near the ankle during a single outpatient procedure under local anesthesia and does not require a preliminary trial phase. Once implanted, targeted stimulation is delivered to the posterior tibial nerve through a lightweight external wearable, allowing patients to activate therapy once daily at home. Importantly, the design does not rely on internal batteries or implanted leads, potentially avoiding device-management issues associated with battery depletion, lead fracture or lead migration. BlueWind also combines the implant with remotely enabled software capabilities, allowing the Revi platform to support evolving therapy functionality while providing patients with greater control over treatment. The company has been developing Implantable Tibial Neuromodulation for UUI since 2010 and views the extended-life implant as the next stage in making the therapy a durable option for long-term management.
Clinical Evidence Supports Long-Term Revi Therapy
The next-generation device builds on clinical evidence generated with the existing Revi System, including three-year findings from the pivotal OASIS study. According to the company, 79% of patients achieved at least a 50% reduction in UUI episodes at three years, while 63% achieved at least a 75% reduction. Patient-reported experience was also favorable, with 95% of participants reporting therapeutic satisfaction through three years of treatment. BlueWind reported no device- or procedure-related serious adverse events through the three-year follow-up period. These findings support the company’s strategy of offering neuromodulation as a minimally invasive treatment option for patients experiencing urgency urinary incontinence. Revi is designed to provide personalized therapy that can adapt to changing symptoms while allowing patients to control when therapy is delivered. The extended 15-year implant lifespan is intended to complement these clinical characteristics by reducing the potential need for replacement procedures over the course of chronic UUI management.
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FDA Clearance Sets Stage for Q4 2026 U.S. Launch
The FDA 510(k) clearance establishes the regulatory pathway for BlueWind Medical to introduce Revi Extend into the U.S. market. The company is targeting a limited U.S. launch during the fourth quarter of 2026, providing selected physicians and patients access to the next-generation system. Urgency urinary incontinence is a chronic condition that can substantially affect everyday activities and quality of life, creating demand for treatment approaches that combine durable symptom management with reduced procedural burden. BlueWind’s Revi platform differs from traditional implanted neuromodulation approaches by pairing a small implanted component with an externally powered wearable, eliminating the need for an implanted battery. With Revi Extend, BlueWind is extending this design philosophy to a projected 15-year treatment horizon. The regulatory milestone strengthens the company’s position in the neuromodulation and urology medical device market and highlights continued innovation in minimally invasive therapies for bladder-control disorders. As the planned commercial introduction approaches, Revi Extend represents a notable development in long-term UUI treatment, implantable neuromodulation and patient-controlled medical technology.
Source: BlueWind Medical press release
